The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.

FDA DeterminedCause 2

OTHER/UNDETERMINED: Pending

Action

An email was sent on 06/15/2010 to the firm's distributors that had products with lot #0809D110 or lot #0307I208 in their possesion. The email was in regards to the distributors' OMG10 granule inventory. The distributors need to return all the recalled granule inventory to be swapped out for new inventory.

Quantity in Commerce

248 units

Distribution

Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.